A good Clinical Evaluation Report should support strong evidence that subject medical device achieves its intended purpose without exposing users and patients to risk.
Data collected, assessed, analyzed by the use a specific medical device on human beings by way of clinical trials, literature search, clinical follow-up, market surveillance, preclinical studies, bench testing and other relevant data sourced to prove medical device intended purpose achieves without exposing users and patients any risk.
A consolidated document covering full details of the device with the proper conclusion of the studies prepared and submitted by the legal manufacturer to Notified Body is called the clinical evaluation report(s).
In another way, CER prepared for the subject medical device as per MDR article 61 & MEDDEV 2.7/1 Rev 4 is considered as a tool to provide the Notified Bodies with a complete overview of the continuous evidence of safety and performance for the medical device.
Due to this reason developing, maintaining and updating medical device clinical evaluation reports became of higher priority for CE Marking across the Globe.
The CER report must be based on data, which may include data from existing literature, human usage experience, human trials, or any combination of the three.
Compared to earlier Rev 3, MEDDEV 2.7/1 Rev 4 has some more requirements that are very difficult to interpret and those new. It may cause delays in the notified body review process if just updating based on literature strategy without Equivalence device analysis will increase your risk of rejection of report by notified bodies
We offer the right strategy starting with GAP analysis of your existing CER report. If required we are here for you to take up the job for updating your present report or develop a new report as per Meddev 2.7.1 Rev. 4.
Clinical Data means the data generated from the use of a medical device with regard to safety and performance. To prove safety and performance of a medical device, clinical evidence must be provided.
There are two possibilities to generate Clinical Evidence.
If applicable, both routes of clinical investigation and clinical evaluation via literature must be used in order to prove clinical safety and performance of a medical device before a device may be placed on the market.
Clinical Evidence is intimately tied to the definition of evidence based from practical usage of medical device by doctors, health organizations and the like use actual research that has been tested on patients to determine best practices in medical devices for variety of procedures.
Systematic investigation on one or more human subjects to evaluate the safety and performance of a medical device (either new technology and or device already in use for many years)
Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of a medical device by complying with respective legal requirments
In Clause 6.2, its a process that must be carried out throughout the life-time for the medical device.
In all cases, the CER Report has to be completed during the pre-market phase, to support the demonstration of safety and performance of the medical device before placing it on the market followed by Report, which must be actively updated to demonstrate the continuous safety and performance of the device.
The CER report needs to be updated at least annually for Class 11b & Class III high risk or case of new devices. In other cases every 2 years.
The person or team creating the report (CER authors and evaluators) must be properly qualified and evidence must be documented.
MEDDEV 2.7/1 Revision 4 requires that each evaluator should fulfill "Statement of Interest" and must also have a higher education degree with 5 years' experience in a similar field of the device in question or 10 years of experience if the degree is not required. Deviations from these requirements have to be duly justified and documented.
We support small, medium and large organization. No matter which type of organizations and customer locations.
Looking for more information on the medical device CER / CER updates as per MDR article 61 & MEDDEV 2.7/1 Rev 4 throughout device life cycle. Write /Contact us. Our team will understand more about the device and guide you as required.
You can download from: https://www.i3cglobal.com/download/MEDDEV-2.7.1-Rev4.pdf
Any experiment in one or more human subjects to assess the safety or performance of a medical device is called clinical Investigation. (Clinical Trial or Clinical Study are synonymous with Clinical Investigation).
Data from Clinical Investigation will address intended purpose, relevant clinical benefits. This data will be taken into Clinical Evaluation to demonstrate compliance with MDR General Safety and Performance Requirements (GSPR)
Preclinical Evaluation is the evaluation of subject device to collect data in support of the safety and performance of the medical device. Preclinical evaluation must done before clinical trials or usage in Human beings.
External Clinical Experts are clinical professionals’ expertise in the subject device, choose and trained by Notified body (NB) for the assessment of Clinical Evaluation and provide advices to NB with respect to the regulations, guidance, common specifications and harmonized standards.